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# 11 Observations in SCA Pharmaceuticals Inspection
- URL: https://www.fdaweb.com/11-observations-in-sca-pharmaceuticals-inspection/
- Published: 2018-04-04T12:00:00.000Z
- Updated: 2026-09-14T23:57:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141144

FDA has released the FDA-483 containing 11 observations issued following a 2/12-3/5 inspection at SCA Pharmaceuticals, Windsor, CT. Specific [observations](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm603280.pdf?ref=fdaweb.com) were: 

- the written stability program for drug products does not include reliable and meaningful test methods;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
- · there is a failure to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- · each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit;
- records for the maintenance and inspection of equipment are not kept;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair;
- testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient before release;
- the responsibilities and procedures applicable to the quality control unit are not fully followed; and
- established test procedures are not followed.