FDA Inspection
BayCare Integrated Service Center LLCBayCare Integrated Service Center LLC – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns BayCare Integrated Service Center LLC, with an inspection on March 12, 2026, issued by the Florida District Office, covering human drugs.
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ID · aeeaf2f0-2947-434c-8324-577a3f98eccb
Inspection Facts
- Inspection number
- 1308216
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of BayCare Integrated Service Center LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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