FDA Inspection
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyInnovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy – FDA Inspection, Dec 18, 2017
Record Details
This FDA Inspection record concerns Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy, with an inspection on December 18, 2017, issued by the Los Angeles District Office, covering human drugs.
- Inspection Date
- December 18, 2017
- Product Type
- Human Drugs
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ID · ac10538e-c144-437a-88d5-734e1a89d756
Inspection Facts
- Inspection number
- 1035243
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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