| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
January 20, 2011
WARNING LETTER
Via United Parcel Service
Mr. Govindasamy Baskaran
Managing Director
Laglove Sdn Bhd (M) aka LA Glove
Lot 478 Jalan Simpang Balak
Off Batu 13, Jalan Cheras
43000 Kajang, Selangor D.E., Malaysia
Dear Mr. Baskaran:
During an inspection of your firm located in Selangor D.E., Malaysia on September 6 - 9, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures FC2 Female Condoms. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate schedules for the adjustments, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities including the date and individual(s) performing the maintenance activities, shall be documented as required by 21 CFR 820.70(g)(1). For example:
a. Your firm’s production manager and the equipment maintenance manager stated that scheduled cleaning of the coagulation tank was done on a (b)(4) basis in keeping with the preventive maintenance schedule and stated there were times when “micro-bubbles” (or small air bubbles) would be observed in the coagulation tank and that maintenance and cleaning would be performed outside of the regular maintenance schedule. Specifically, your procedure for cleaning the coagulation tank, “Start Up and Cleaning Procedure for the Nitrile Sheath Forming Machine,” (Doc No: SOP/PRD/34, Issue: 01, Rev. 01, effective June 1, 2009) and your firm’s “Nitrile Sheath Forming Trouble Shooting Guide,” (Doc No: SOP/PRD/33, issue: 01, Rev: 00, effective June 1, 2008) did not explain how non-scheduled maintenance would be documented. Your firm did not always document instances when adjustments or non-scheduled cleanings of the coagulation tank were performed.
b. It was observed by the investigator on September 7, 2010 that the timer for the Dryer Machine #5 in the Nitrile Sheaths Process Area was not working. There was no documentation on the equipment maintenance schedule to determine appropriate steps were taken to repair the timer. The most recent preventive maintenance of Dryer Machine #5 was last performed on July 22, 2010.
2. Failure to adequately ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).
For example, your firm had not replaced the clock in the nitrile compounding area that was used to measure the mixing time of: a) the chemicals used in the manufacturing of the nitrile sheath and b) the nitrile compound. As a result, a compounding employee on the ((b)(4) shift ((b)(4) shift) was observed using the clock alarm feature on (b)(4) to measure the mixing time for both of the aforementioned items.
3. Failure to establish and maintain adequate procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality. Environmental control system(s) shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. These activities will be documented and reviewed, as required by 21 CFR 820.70(c).
For example, dust and particulate matter were observed during the inspection on some surfaces along the base and sides of the ovens, which are above the open coagulation and latex tanks.
4. Failure to adequately evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1).
For example, your firm's procedure entitled, “Purchasing” (Doc No: QP/PUR/01, Issue: 02, Rev: 00, effective May 1, 2008), does not explain the supplier evaluation criteria. Specifically, the procedure does not explain how a supplier (vendor) will be assigned a rating (i.e., Excellent, Good, Satisfactory or Unsatisfactory) for individual performance measures, such as "Incoming QC Status Remarks" (meaning the number of incoming Lots that were delivered to the firm which met all of its specifications). Your firm, in evaluating (b)(4), your supplier of the Nitrile Compound for the year 2009, gave the supplier a rating of "Good" for each performance measure (including that of QC Status Remarks), but assigned (b)(4) an overall rating (score) of "Excellent".
5. Failure to establish and maintain adequate procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups, as required by 21 CFR 820.60.
For example, your firm's procedure entitled, "Control of Handling, Storage and Preservation" (Doc No: SOP/STO/01, Issue No: 01, Rev: 01, effective July 22, 2008), specifies that "finished products accepted by (b)(4)(b)(4) are stored on pallets in the finished store" area. On September 7, 2010, a pallet containing (b)(4) cartons of finished nitrile sheaths was observed in the finished store area, which is located (b)(4). However, the (b)(4) cartons, which were part of Lot # (b)(4), had not yet been released by your firm's Quality Control and there was no sticker or other identifier on the cartons or the pallet indicating the status of the product.
6. Failure to establish adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
For example, with regards to your employees involved in the compounding of the nitrile compound (which is used to make the nitrile sheath), a review of your firm's training procedure, entitled, "Training Needs Identification and Training Plan" (Doc No: QP/HRM/01, Issue: 02, Rev: 01, effective date: July 1, 2009) and employee training records gave no indication that employees were made aware of the defects or negative impact on the medical device that may occur from the improper performance of their job.
7. Failure of management with executive responsibility to adequately review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, your firm's procedure entitled, “Management Review” (Doc No: QP/MGT/01, Issue: 02, Rev: 01, effective July 1, 2009), states that vendor performance shall be covered in each management review meeting. However, the agenda items for the management reviews conducted on September 27, 2008 and January 23, 2010, did not list vendor (supplier) performance as an agenda item, nor were any indications given that this topic was covered under any of the other listed agenda items.
A follow up inspection will be required to assure the corrections are adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)) Also, U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: Field Operations Branch, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Silver Spring, Maryland, 20993, U.S.A. If you have any questions about the content of this letter please contact: Ronald T. Nowalk at (telephone) 301-796-5493 or (fax) 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/s/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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