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# 16 Observations in Pharm D Solutions FDA-483
- URL: https://www.fdaweb.com/16-observations-in-pharm-d-solutions-fda-483/
- Published: 2018-09-26T12:00:00.000Z
- Updated: 2026-09-15T00:34:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142444

FDA has released the FDA-483 issued following an 8/13-8/28 inspection at Pharm D Solutions, a Houston, TX, outsourcing facility. The 16 observations on the [form](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm621347.pdf?ref=fdaweb.com) were: 

- failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- the quality control unit lacks the responsibility and authority to approve and reject all in-process materials and drug products;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements;
- testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release;
- failing to have written procedures for production and process controls to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the sterilization process;
- aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform;
- failing to have a written testing program designed to assess the stability of drug products;
- failing to write and follow procedures designed to assure that correct labels, labeling, or packaging materials are used for drug products;
- batch production and control records do not include complete labeling control records, including specimens or copies of all labeling for each batch of drug product produced;
- labels of the outsourcing facility’s drug products are deficient; and
- the outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six-month period.