Import Alert vs. Warning Letter? | Redica Systems (2024)

by Barbara Unger, FDAzilla GMP Quality Expert

INDIA |IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites |Detention Without Physical Examination of Drugs from FirmsWhich Have Not Met Drug GMPs

In this post, I consider the active import alerts in the “66-40” category currently posted on the FDA website for firms located in India and the frequency with which warning letters are associated with the import alerts.The tabulated data does not identify import alerts that may have been put in place and removed within this time period.Addresses are often difficult to unambiguously align, but I’ve made every attempt to do so.Where warning letters have been issued, most link(s) are provided.

FROM THE FDA WEBSITE DESCRIBING IMPORT ALERT 66-40: “Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP’s).

Detention without physical examination (DWPE) may also be appropriate when the FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that reveals conditions or practices warranting detention of either particular products or of all products manufactured by a firm.

DWPE of such firms remains in effect until such time as the FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation to the responsible FDA Center.

CONCLUSION:

• Currently 41 sites in India are under import alert for failure to comply with GMPs (Table 3).
• For these 41 sites, twenty-one of them, just under half do NOT have associated warning letters. Thus, being placed under import alert is no guarantee that a warning letter will be issued regarding the site nor is receiving a warning letter a guarantee of an import alert (Table 1).
• Among the active import alerts in this category, four have been issued to a single company, one firm has 3 sites under import alert, nine (9) firms have two sites under import alert and sixteen (16) have a single site under import alert.The firm with four sites is Sun Pharmaceuticals, and this includes sites that Sun acquired in their purchase of Ranbaxy Pharmaceuticals (Table 2).
• In three instances, EU reports of GMP non-compliance issued based on inspections in a similar timeframe.They are identified in Table 3 and summary reports may be found HERE.

TABLE 1: Import Alerts per Calendar Year

Figure 1. Import Alerts by Year and Those Without Associated Warning Letters

TABLE 2: Active Import Alerts (66-40) per Company Site in India, 2009 – 2016 to date

Table 3: Listing of firms/sites in India currently under Import alert 66-40, by Date of Issue

Links are provided to associated warning letters on the FDA website