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# Pentec Health FDA-483
- URL: https://www.fdaweb.com/pentec-health-fda-483/
- Published: 2018-03-08T12:00:00.000Z
- Updated: 2026-09-14T23:28:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140933

FDA has released the FDA-483 issued following a 2/5-2/23 agency inspection at Pentec Health, a Boothwyn, PA, outsourcing facility. The five specific observations in the document were: 

- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- batch production and control records do not include complete information relating to the production and control of each batch;
- the responsibilities and procedures applicable to the quality control unit are not in writing;
- time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product; and
- written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.