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Quality and purity concerns The investigation found that active pharmaceutical ingredients (APIs) were allegedly being imported illegally and that there was no adequate analytical testing to confirm: Identity of the ingredients Potency of the medication Purity of the product Consistency between batches Without proper testing, patients cannot be certain what they are injecting

Even if the FDA ultimately denies the petition (which it does in the vast majority of cases where the petition appears primarily motivated by competitive concern rather than genuine safety issues), the review process takes time often three to six months during which the competitors approval is effectively delayed

When to Expect Results: The company does not publish a week-by-week guaranteed timeline