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Wockhardt — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Wockhardt (NSE: WOCKPHARMA, BSE: 532300), from US FDA records and exchange filings.
70
Compliance score (5 years) · how
0
USFDA-inspected plants on record
0
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: Added to FDA import alert 66-40 — 05 Aug 2016. Source: FDA import alerts.
USFDA events by year
2013
2016
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| No plant inspections matched to Wockhardt in the data collected so far. | ||||
Full USFDA timeline
29 May 2026
US approval
USFDA approval: ZAYNICH
NDA220787 — CEFEPIME HYDROCHLORIDE, ZIDEBACTAM (Type 1 - New Molecular Entity and Type 4 - New Combination)
Source: openFDA Drugs@FDA ↗
05 Aug 2016
Import alert
Added to FDA import alert 66-40
Wockhardt, Ltd., Sf-12 Shrinathji Arcade Plot 138, Bulk Drug Division; Karmatur Road, Ankleshwar, Gujarat INDIA
Source: FDA import alerts ↗
26 Nov 2013
Import alert
Added to FDA import alert 66-40
Wockhardt Limited, L-1, MIDC Area, Jalgaon Road 43, Chikalthana, Aurangabad, Maharashtra INDIA
Source: FDA import alerts ↗
22 May 2013
Import alert
Added to FDA import alert 66-40
Wockhardt Limited, H - 14/2 Midc Area, Waluj, Aurangabad, Maharashtra INDIA
Source: FDA import alerts ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/wockhardt