# FDA 483 - Bayview Pharmacy, Inc. - August 18, 2016

Source: https://www.keypedia.com/records/483/bayview-pharmacy-inc/ceb2f214-29c4-47b4-917a-641e2a5b65bf

> FDA 483 for Bayview Pharmacy, Inc. on August 18, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayview Pharmacy, Inc.
- Inspection Date: 2016-08-18
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 inspection revealed multiple violations concerning aseptic processing, environmental control, and cross-contamination prevention. Personnel were observed blocking first-pass air in the ISO 5 zone, reaching into the Laminar Flow Hood with non-sterile attire (frock, dust mask, hair cover exposing face/eyes), and compromising sterility by placing vial stoppers face-down on a wipe. On 08/09/2016 and 08/10/2016, a pharmacist's upper body and head broke the ISO 5 plane during aseptic filling of Acetylcysteine 10% (PF) Nebulizer INH SOLN (Lot # 08082016@10) and TRI-MIX, leading to lot discards. Logged Formula Worksheets were placed in the ISO 5 hood, potentially disrupting airflow, also resulting in lot discards for Acetylcysteine and TRI-MIX.

The ISO 7 Cleanroom temperature reached 79°F on 08/09/2016, causing visible perspiration, with logs showing temperatures exceeding 78°F on twelve days (May 2016-present), peaking at 81°F. Facility design allowed poor quality air into higher classified areas, and no dynamic airflow assessment existed for the ISO 5 hood.

Highly potent drugs, including hormones (progesterone, estradiol

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-08-14](https://www.keypedia.com/records/state_referral_letter/bayview-pharmacy-inc/87968019-0a6c-4530-bc15-c34e45d5c074)

## Related Officers

- [Nealie C. Newberger](https://www.keypedia.com/people/nealie-c-newberger/4b7addde-1217-4495-bac2-2f7e3fe2e780)

Company: https://www.keypedia.com/companies/bayview-pharmacy-inc/2ffddf86-b146-44ed-8d70-16a640b3c564

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144