| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 26, 2011
WL 35-11
James L. Stroud
President/Chief Executive Officer
Golden State Medical Supply, Inc.
5187 Camino Ruiz
Camarillo, CA 93012-8601
Dear Mr. Stroud:
During our January 19, 2011 to February 2, 2011 inspection of your pharmaceutical manufacturing facility, Golden State Medical Supply, Inc., located at 5187 Camino Ruiz, Camarillo, California, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We acknowledge your written response, dated February 25, 2011, to the Form FDA 483. However, because this response was received more then 15 business days after the Form FDA 483 was issued, the response has not been considered. We plan to evaluate your response to the Form FDA 483, along with any other written material provided, as a direct response to this Warning Letter.
Specific violations observed during the inspection include, but are not limited, to the following:
1. Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192]. For example:
A. Your firm failed to thoroughly investigate the complaints received between November 2010 to December 2010, for discolored Clorazepate Dipotassium tablets (lots (b)(4), (b)(4) and (b)(4)). Although the manufacturer suggested possible root causes, including the use of containers with a different head space, your firm did not: 1) take any action to investigate these possible root causes; 2) implement corrective actions; and 3) evaluate other batches of the same drug product or other drug products that could have been impacted.
Since January 10, 2011, your firm received communications from the original drug product manufacturer stating that the Clorazepate Dipotassium tablets were (b)(4) and (b)(4) and that your firm’s selected container closure to repackage this drug is a different size resulting in a (b)(4) head space. A (b)(4) head space will contribute to the discoloration of the tablets. Despite these communications, your firm continued to use the same container closure with the (b)(4) head space.
B. Your firm did not conduct an investigation into the following deviations identified during the annual product review to determine the cause and possible impact upon the quality of the distributed drug products:
i. (b)(4) retain bottles containing discolored tablets (i.e. (b)(4) of Paroxetine 20 mg, (b)(4) of Ranitidine 150 mg, (b)(4) of Ranitidine 300 mg, and (b)(4) of Trazodone 100 mg).
ii. (b)(4) instances of missing desiccants.
iii. (b)(4) instances of “bad” seals.
iv. (b)(4) instances where there were missing seals on retain drug products.
This is a repeat observation from the December 15, 2010 inspection.
2. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates [21 C.F.R. § 211.166(a)]. For example, your firm has not conducted an adequate comparison to determine whether your container closure is as protective as the original manufacturer’s container closure despite your use of the manufacturer’s original expiration date. In addition, your firm has not established specifications for your container closure system.
3. Your firm has failed to separately store labels and other labeling materials for each different drug product, strength dosage form, or quantity of contents in an area limited to authorized personnel [21 C.F.R. § 211.122(d)]. For example, your firm stores drug product insert and outserts for repacked drug products in the quarantine area without limiting access to authorized personnel.
4. Your firm’s records failed to include an individual inventory record of each drug product container and closure with sufficient information to allow the determination of any batch or lot of drug product associated with the use of each product container and closure [21 C.F.R. § 211.184(c)]. For example, your firm has failed to document the drug product lot numbers associated with the containers, closures, caps, and desiccants used in repacking. Without such information, your firm is unable to identify or track these drug products when there are failures, complaints, or recalls.
5. Your firm has not followed written procedures for cleaning and maintenance of equipment [21 C.F.R. § 211.67(b)]. For example, your firm has failed to follow your procedure P148.15, “Periodic Maintenance of Production Equipment,” requiring a (b)(4) maintenance schedule. Our inspection identified the lack of any scheduled equipment maintenance (e.g., calibration checks of digital scales) for the “(b)(4)” room between March and December 2010, and the “(b)(4)” room between April and September 2010.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute drug product(s), and provide the date(s) and reason(s) you ceased production.
Your reply should be sent to the following address: Food and Drug Administration, Attention: Blake Bevill, Director Compliance Branch, 19701 Fairchild, Irvine, California 92612-2445.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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