FDA Slaps 3 Compounders With Warning Letters
The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry last year.
Compounders have struggled to meet the agency’s guidelines as it adjusts to being regulated by the FDA and not solely by state pharmacy boards.
Advanced Physician Solutions was reprimanded for dispensing drugs without valid prescriptions for individually identified patients. More importantly, investigators noticed serious deficiencies in the North Hollywood, Calif.-based compounder’s sterile product production, the Nov. 3, 2015, warning letter says.
During the Jan. 12 to 16, 2015, inspection, investigators observed an external air conditioning unit installed on the cleanroom wall across from the hoods where aseptic production occurred. The company had no data to indicate that a HEPA filter was installed in the air conditioner and did not assess whether the AC unit affected aseptic operations, the warning letter states.
The company also failed to conduct studies that the aseptic compounding equipment and hoods are able to provide adequate sterile protection. The warning letter notes that products “may be produced in an environment that poses a significant contamination risk.”
In addition, APS also produced a near identical copy to AMAG Pharmaceuticals’ Makena, a drug to prevent premature births. Compounders are not allowed to produce what are essentially copies of a commercially available drug, the FDA said.
As of April 3, 2015, APS ceased operations and notified the FDA that it has no plans to resume sterile compounding. The next month, the company recalled all remaining sterile product in the market.
Meanwhile, Triangle Compounding Pharmacy received a warning letter following a Jan. 12 to 16, 2015, re-inspection of its Cary, N.C., facility. The reinspection was conducted to determine if compliance had been achieved following an original Sept. 8 to 22, 2014, inspection.
Triangle was producing chlorhexidine gluconate products for use in patient preparations. However, products containing that ingredient have been removed from the market because they are unsafe, the FDA said.
Triangle also failed to report to the FDA products that it compounded six months prior to registering as an outsourcing facility. Additionally, the company did not investigate batch failures and lacked written procedures designed to assure batch uniformity and integrity of drug products.
The warning letter also notes that Triangle failed to ensure container closure systems provide protection against deterioration or contamination of drug products. The company also was dinged for not establishing an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
In addition, during a Dec. 15 to 31, 2014, inspection of McGuff Compounding Pharmacy Services, investigators observed that the company does not receive valid prescriptions for individually identified patients for a portion of the drug products it produces. Additionally, the products’ labeling fails to include adequate directions for their intended uses.
In a response to an April Form 483 that predated the Nov. 13, 2015, warning letter, the Santa Ana, Calif.-based compounder says it has converted to “100 percent patient prescription orders” and will no longer take orders for “office use” by healthcare providers.
McGuff and Triangle did not return a request for comment by press time.
Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.