FDA Inspection
Hyalynx IncHyalynx Inc – FDA Inspection, Jun 27, 2019
Record Details
This FDA Inspection record concerns Hyalynx Inc, with an inspection on June 27, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · acada0b1-77c6-490d-9af3-ab73dc644473
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094297
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Hyalynx Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 20, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 31, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hyalynx Inc
- FDA Inspection 971491 - 2016-05-18
- FDA Inspection 967941 - 2016-04-20
- FDA Inspection 864796 - 2014-01-31
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