FDA Inspection
Rancho Park Compounding PharmacyRancho Park Compounding Pharmacy – FDA Inspection, May 7, 2019
Record Details
This FDA Inspection record concerns Rancho Park Compounding Pharmacy, with an inspection on May 7, 2019, issued by the Los Angeles District Office, covering human drugs.
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ID · 2caef489-ea61-45de-9219-6ac933d912b2
Inspection Facts
- Inspection number
- 1089769
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- FDCA 501(a)(2)(A)Ceiling tiles, cleanroom
- FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
- FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)Dust-collecting overhangs, surrounding area of ISO 5
- FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
- FDCA 501(a)(2)(A)Flow of personnel and materials, facility
- FDCA 501(a)(2)(A)Improper gowning, contamination
- FDCA 501(a)(2)(A)Non-microbial contamination, production area
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