# FDA 483 - Boothwyn Pharmacy LLC - October 22, 2024

Source: https://www.keypedia.com/records/483/boothwyn-pharmacy-llc/31439341-9a02-4d11-86c6-101e23daf717

> FDA 483 for Boothwyn Pharmacy LLC on October 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boothwyn Pharmacy LLC
- Inspection Date: 2024-10-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details significant deficiencies in a drug manufacturing operation, primarily concerning quality control and sterile product procedures.

**Observation 1** highlights failures in drug product testing and release. The firm distributed seven batches of drug products, including HA/CHONDROITIN/ACETYL-D-GLUCOSAMINE (100Ml) 5MG/50MG/150MG/Ml INJ SOLUTION, with false passing bacterial endotoxin testing (BET) results on Certificates of Analysis (COAs), despite the contracted laboratory's database indicating Out of Specification (OOS) results. Additionally, approximately thirty-one compounded drug products, such as Pentosan and Glucosamine injection solution, lot # 01152024, were distributed despite confirmed OOS BET results. The firm also failed to conduct BET for approximately six batches of glucosamine-containing products, including various HA/CHONDROITIN/ACETYL-D-GLUCOSAMINE and PENTOSAN POLYSULFATE AND GLUCOSAMINE injection solutions, before distribution.

**Observation 2** addresses inadequate procedures to prevent microbiological contamination in sterile drug products. Air visualization "smoke" studies were insufficient; media fills and smoke studies were not representative of production operations, with a second operator entering the ISO 5 environment while the filling technician was present, violating SOP CP.CTECH.0040.000

## Related Documents

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Julia N. Alvarez](https://www.keypedia.com/people/julia-n-alvarez/481db374-5114-4f0d-b30b-1c46d09db8a1)
- [Rahi D. Patel](https://www.keypedia.com/people/rahi-d-patel/aa11c863-2b54-4b1d-afe4-fd8fa715faee)
- [Investigator ](https://www.keypedia.com/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)

Company: https://www.keypedia.com/companies/boothwyn-pharmacy-llc/3ac2c2e2-f194-4c53-9125-a7e1bb4a02c4

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c