# Helena Laboratories, Corp. – FDA Inspection, Jul 21, 2017

Source: https://www.keypedia.com/records/fda_inspections/helena-laboratories-corp/86bce6a3-dd81-4f06-8a99-8f01698ec8ea
Source feed: FDA_Inspections

> FDA inspection 1018711 of Helena Laboratories, Corp., July 21, 2017. Classification: Official Action Indicated (OAI). 8 citations under 21 CFR parts 806 and 820. Form 483 issued. 3 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1018711
- Company Name: Helena Laboratories, Corp.
- Inspection Date: 2017-07-21
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 8

## Related Documents

- [FDA Inspection 1074463 - 2018-12-14](https://www.keypedia.com/records/fda_inspections/helena-laboratories-corp/cb1d01a8-02e8-4222-96c5-3ece78757b47)
- [FDA Inspection 820597 - 2013-03-01](https://www.keypedia.com/records/fda_inspections/helena-laboratories-corp/92e8404f-4bfd-4aba-8b2d-bf38577293de)
- FDA Inspection 694963 - 2010-10-29

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.keypedia.com/companies/helena-laboratories-corp/9742bc61-dee7-4b93-a33a-0581bd422d44

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7