| Public Health Service Food and Drug Administration |
San Juan District Compliance Branch 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 TEL (787) 474-9500 FAX (787) 729-6658 |
Department of Health and Human Services
April 19, 2011
WARNING LETTER
11-SJN-WL-08
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. David Velazquez,
General Manager
Biolab Company
P.O. Box 2006
Bayamon, PR 00960
Dear Mr. Velazquez:
During an inspection of your firm located at Ave. Teniente Nelson Martinez N-59 Alturas de Flamboyan, Bayamon, PR 00959 conducted from 02/02/11 through 03/01/11, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II culture medias used for in-vitro diagnosis and antimicrobial susceptibility tests. 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.
The inspection found that your culture media 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.
On 03/01/11, our investigator issued to you a list of deficiencies documented on Form FDA 483, List of Inspectional Observation. These violations include, but are not limited to, the following:
1. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications as required by 21 CFR § 820.70(a).
For example,
- In January 2010 you failed to identify that your Sterilizer# (b)(4), used to sterilize your culture medias, had failed its (b)(4). Your sterilized culture medias are used by clinical laboratories for the diagnosis of illnesses and diseases in patients. There is no assurance that at least 136 lots of multiple culture medias released for distribution to several clinical laboratories and hospitals in December 2009 through February 2010 were appropriately sterilized.
- Your current control measures used to ensure that there is no microbial contamination inside your clean rooms are not adequate. You failed to provide data to show that placing four (4) (b)(4) plates inside each of the clean rooms for 10 minutes after you sanitized the clean rooms could determine that you have a sanitized clean room for one day of production. In addition, the outlets of the air handling unit located inside the clean rooms are not equipped with any filter to prevent the entrance of viable and non viable particles. Also, you failed to provide data during the inspection that could show that spraying a commercial disinfecting spray inside the air ducts is an effective measure to ensure the sanitization of the air ducts. Furthermore, you failed to provide records to show this sanitization process is currently done in your clean rooms.
Please include information, in your response to this letter, of the status of your investigation related to the sterility issue found by our Investigator. We acknowledge that all the culture medias associated to this incident expired but we are interested to know if you identify the root cause of the problem to ensure that adequate corrective and preventive actions were implemented. In addition, we want to know the steps that you have taken to ensure that your sanitization practices in the clean rooms are effective.
2. Failure to validate with a high degree of assurance and approve according to established procedures the results of a process which cannot be fully verified as required by 21 CFR § 820.75(a).
Specifically, your firm failed to provide documented evidence to show that the parameters used for your current moist sterilization process used to sterilize all your culture medias are adequate. In addition, you failed to show that your current sealing process, used during your packaging activities do not compromise the sterility of your products.
In your response to this letter, please indicate the steps that you have taken to start validation activities for your current sterilization and sealing processes to ensure the effectiveness and reproducibility of your operations.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR § 820.198 (a). In addition, you failed to investigate complaints associated to the possible failure to a device as required by 21 CFR § 820.198 (c).
This is a repeat deficiency cited in our 2008 inspection.
Specifically, your current recall, CAPA, and investigation procedures, which your firm is currently using to process complaints, are inadequate because these procedures fail to provide specific information on how to process complaints. In addition, about 52% of the complaints received by your firm since 2008 are related to microbial contamination and not all were investigated.
4. Failure to have a Corrective and Preventive Action (CAPA) procedure that includes requirements for analyzing processes, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems as required by 21 CFR§ 820.100 (a).
5. Failure to establish and maintain a procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90 (a).
This is a repeat deficiency cited in our 2008 inspection.
6. Failure to establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) as required by 21 CFR 820.184.
Specifically, your firm lacks a standard operating procedure that requires that the device history record of each lot of culture media contains all the required manufacturing information. A review of several of your DHRs found that they were missing the amount of dehydrated media used, the part numbers of the Petri dishes used, and labeling information. All these information is important in case of a recall action.
7. Failure to conduct quality audits following the requirements established in 21 CFR§ 820.22.
Specifically, your firm’s supervisor is in charge of performing quality audits of all manufacturing, cleaning, and sanitizing records to assess if they were completed in accordance to your procedures. Nevertheless, to be in compliance with the Quality System Regulation internal audits must be conducted by individuals who do not have a direct responsibility for the matters being audited.
8. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately performed their assigned responsibilities as required by
21 CFR§ 820.25 (b).
21 CFR§ 820.25 (b).
This is a repeat deficiency cited in our 2008 inspection.
The multiple deficiencies found during this inspection show that your personnel have not been adequately trained in the requirements of the Quality System Regulation. In addition, you were not able to show during the inspection that your personnel received on the job training for their specified assigned tasks.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Repeat citations from prior inspections indicate that your quality control unit is either not appropriately exercising its responsibilities or does not have the authority to carry out its responsibilities. Due to continuing QSR deviations at your firm, we recommend you engage a third party consultant having appropriate QSR expertise to assess your firm’s facilities, procedures, processes, and systems to ensure that your devices are manufactured in accordance to applicable regulations.
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 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 bring your products into compliance.
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.
Your reply should be sent to the following address: Food and Drug Administration, Attention: Margarita Santiago, Compliance Officer, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Ms. Santiago at (787) 474-4789 or by electronic mail at margarita.santiago@fda.hhs.gov.
Sincerely,
/S/
Maridalia Torres
District Director
San Juan District
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